Quality Improvement and Clinical Utility PrecivityAD2(TM) Clinician Survey

Active, not recruiting

• Conditions: Mild Cognitive Impairment; Cognitive Impairment; Dementia; Alzheimer Disease; Cognitive Decline; Memory Impairment
• Interventions: Other: PrecivityAD2(TM) blood test

• Registration Number: NCT06025877
• Lead Sponsor: C2N Diagnostics

Brief Summary

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022).

Detailed Description

The Quality Improvement PrecivityAD2(TM) Clinician Survey and Clinical Utility Study (QUIP II) represents a large-scale initiative for the PrecivityAD2 blood test for use by neurologists, geriatricians, and geropsychiatrists (memory care specialists) who see patients aged 55 years and older with signs or symptoms of MCI or dementia.

C₂N Diagnostics, LLC is a CLIA-certified, CAP-accredited diagnostic testing laboratory based in St. Louis, MO. Its new test, the PrecivityAD2 blood test, measures plasma amyloid beta (Aβ) peptides 42 and 40 (Aβ42/40) Ratio and phosphorylated tau (p-tau) compared to non-phosphorylated tau (np-tau) at amino acid 217 of the tau peptide (p-tau217/np-tau217) ratio to determine whether a patient with signs or symptoms of cognitive impairment is likely to have brain amyloid plaques, a pathological hallmark of AD.

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-06
• Study Start: 2023-11-15
• Status Verified: 2024-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Memory care specialists actively practicing in the United States
2. Practice serves individuals with MCI or dementia age > 55 years
3. Average patient volume > 25 visits per week (all patients seen across practice)
4. Memory care specialist with access to an online electronic survey

Physician

Exclusion Criteria

1. Clinicians who practice in New York

Participant Inclusion Criteria:

1. Individual with MCI or dementia
2. Age >= 55 years

Participant Exclusion Criteria

1. Individual requiring test related blood draw within the state of New York
2. Participation does not seem to be in the best interest of the individual, per the ordering clinician

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	PrecivityAD2(TM) blood test	Pre-test as well as post-test and close-out survey following the receipt of the PrecivityAD2 blood test result
Cohort A	PrecivityAD2(TM) blood test	One time clinician survey post-test following the receipt of the PrecivityAD2 blood test result

Primary Outcome Measures

Name	Time	Method
Change in planned clinical management (Cohort A and B)	Day 20	The association of the test result on medical decision making
Change in planned clinical management (Cohort B)	Day 0 vs Day 20	Evaluate the planned versus subsequent planned change in clinical management as a result of receiving the test result
Difference between the actual age and symptomatology versus intended use criteria (Cohort A and B)	Day 90	Evaluate the intended use criteria

Secondary Outcome Measures

Name	Time	Method
Relationship between the test result and actual clinical management (Cohort B)	Day 90	Association of the test result on subsequent conducted changes in clinical management and test results when evaluating individuals with MCI or dementia in an ambulatory setting
Change in planned clinical management compared to conducted clinical management (Cohort B only)	Day 20 vs Day 90	The evaluation of planned versus conducted change in management as a result of receiving the test result
Change in probability of AD (Cohort A and B)	Day 0 vs Day 20	Evaluate the probability of an AD Dx pre and post receipt of the test result
Change in anti-AD medication use (Cohort A and B)	Day 0 vs Day 20	Evaluate anti-AD medication use pre- and post-receipt of the test result
Relationship between the test result and planned testing (Cohort B)	Day 0 vs Day 20 vs Day 90	Evaluate the association between subsequent test ordering pre and post testing
Change in diagnosis (Cohort B)	Day 0 vs Day 90	Evaluate any changes in diagnoses as a result of receiving the AD test result
Correlations between the net promoter score and ease of use by APS2 result (Cohort B)	Day 90	Focus group questions around net promoter score and ease of use, strengths, and limitations of testing

Trial Locations

Locations (9)

UCSF Memory and Aging Center; 🇺🇸 San Francisco, California, United States

Tulane Doctors Neurosurgery Clinic; 🇺🇸 New Orleans, Louisiana, United States

C2N Diagnostics; 🇺🇸 St. Louis, Missouri, United States

Palmetto Primary Care Physicians; 🇺🇸 Summerville, South Carolina, United States

Pacific Brain Health Center; 🇺🇸 Santa Monica, California, United States

Advocate Memory Center; 🇺🇸 Park Ridge, Illinois, United States

Josephson Wallack Munshower Neurology, P.C.; 🇺🇸 Indianapolis, Indiana, United States

Memorial Healthcare Institute for Neuroscience; 🇺🇸 Owosso, Michigan, United States

Sharlin Health and Neurology; 🇺🇸 Ozark, Missouri, United States